China Tongxinluo Study for Myocardial Protection in Patients With Acute Myocardial Infarction
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 3,796
- 试验地点
- 7
- 主要终点
- MACCE
研究概览
简要总结
To determine the therapeutic effects of Tongxinluo Capsules as compared with placebo in the treatment of patients with acute ST-elevation myocardial infarction (STEMI): (1) Clinical efficacy and safety at 30 days: the incidence of composite endpoints comprising major adverse cardiovascular and cerebrovascular events (MACCE, including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke), severe complications (including cardiogenic shock, heart failure, mechanical complications and malignant arrhythmias), and major bleeding (BARC grade III and V); (2) Clinical efficacy and safety at 1 year: the incidence of composite endpoints comprising MACCE, hospitalization due to heart failure, in-stent thrombosis, and major bleeding (BARC grade III and V), as well as all-cause mortality; (3) the effects in promoting myocardial reperfusion, reducing incidence of myocardial no-reflow, protecting ischemic myocardium, minimizing infarction size, and improving left ventricular systolic function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age>18 years;
- •Within 24 hours of infarctional chest pain onset;
- •ECG shows ST-segment elevation ≥0.2mV in more than 2 adjacent leads, or new left bundle branch block (LBBB);
- •Voluntary participation in the study with consent forms signed.
排除标准
- •Critically illness due to STEMI;
- •Long-term (>20 min) cardio-pulmonary resuscitation (CPR);
- •Suspected aortic dissection or acute pulmonary embolism;
- •Explicit mechanical complications, including interventricular septum perforation, rupture of papillary muscles and chordae tendineae, or on-going or ruptured left ventricular free walls.
- •Serious cardiogenic shock and do not responding to hypertensive agents;
- •Uncontrolled acute left heart failure or pulmonary edema;
- •Malignant arrhythmias uncontrolled by anti-arrhythmia agents;
- •Bleeding history of cerebral vessels, gastrointestinal tract, respiratory tract, urinary tract or other organs within 1 month;
- •Presence of active hemorrhage at any part of the body (including menstruation);
- •Known hemorrhagic constitution or serious hemostasis and blood coagulation disorders;
- •Current usage of anticoagulants (such as Warfarin or new anticoagulants);
- •. Serious hepatorenal dysfunction [ATL≥5 ULN (upper limit of normal), Cr>134μmol/L (2mg%) or eGFR<45ml/min/1.73m2];
- •Serious chronic obstructive pulmonary disease (COPD) or respiratory failure;
- •. Severe infection:
- •. Very weak or frailty;
- •. Neuropsychiatric system diseases;
- •. Malignancies;
- •. Other pathophysiological conditions with expected survival time <1 year;
- •Allergy to the ingredients of this investigational drug;
- •Women who are in pregnancy or nursery;
- •Participation in clinical study of other traditional Chinese medicine (TCM);
- •Unsuitability to participate in this study due to other diseases.
研究组 & 干预措施
Experimental group
First time given 8 capsules of Tongxinluo, then given 4 capsules of Tongxinluo, tid, po.Dosage form: capsule;Dose: 0.26g/capsule;Duration:1 year
干预措施: Tongxinluo (Drug)
Control group
First time given 8 capsules of placebo, then given 4 capsules of placebo, tid, po.Dosage form: capsule;Dose: 0.26g/capsule;Duration:1 year
干预措施: Placebos (Drug)
结局指标
主要结局
MACCE
时间窗: 30-day
30-day incidence of composite endpoint events comprising MACCE (including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke)
次要结局
- Revascularization(30-day)
- Cerebral stroke(30-day)
- STEMI(30-day)
- The incidence of bleeding in BARC（Bleeding Academic Research Committee Bleeding Standard） III and V(30-day)
- MACCE(1 year)
- In-stent restenosis(1 year)
- All-cause mortality rate at 1 year(1 year)
- Myocardial reperfusion and no-reflow(2 hours, 24 hours and 7 days)
研究者
fuwaihospital
Assistant dean
China National Center for Cardiovascular Diseases